Kornimate/medical-research-clean huggingface dataset:
recombinant human erythropoietin use in intensive care unit (icu) patients: does it prevent acute renal failure

Conditions: Acute Renal Failure

Summary: pilot study aiming to assess the effect of two doses of rhu epo on urine ngal concentration and on serum cystatin c and creatinine levels in critically ill patients at risk of arf.

research plan open-label randomized trial twelve months duration trial setting: medical and surgical intensive care unit of the university hospitals of geneva start of trial: mid-may 2008 patients randomly allocated to 2 treatment groups (20 patients per group), or a control group (40 patients): * group 1: control group (40 patients) * group 2 : 20000 iu rhu epo (20 patients) administered by the i.v. route * group 3 : 40000 iu rhu epo (20 patients) administered by the i.v. route 3.2. trial design day 0 consent form signed patients randomly allocated to control or treatment groups (20000 and 40000 iu) serum cystatin c determination serum creatinine determination urinary ngal determination administration of intravenous rhu epo on day 0 or no epo (control group) day 2 at 48 hr after rhu epo injection, samples will be taken for * serum cystatin c determination * serum creatinine determination * urinary ngal determination day 4 at 96 hr after rhu epo injection, samples will be taken for * serum cystatin c determination * serum creatinine determination * urinary ngal determination stopping rules the trial for an individual subject, parts of the trial or the entire trial will be stopped when: * at day 4 for an individual subject * after enrollment of 80 patients treatment the treatment will consist of intravenous (i.v.) injections of recombinant human erythropoietin (r-hu-epo). the trial medication will be provided by janssen-cilag ag. the brand name is eprex® which is epoietinum-alpha in sterile buffered solution for i.v. or s.c. injection. patient group 1 will not receive epo treatment. patient group 2 will receive 20'000 u of rhu epo and patient group 3 will receive 40'000 u of rhu epo (i.v. route).

Eligibility criteria:
inclusion criteria: * patients at risks for acute tubular necrosis (patients with mechanical ventilation, patients with sepsis, in the post-operative state, with hemodynamic impairment or with previous chronic renal failure. * consent form signed exclusion criteria: * patients with malignant hypertension * patients with systolic bp \> 150 mmhg at enrollment * patients with hb level \> 120g/l * patients with acute coronaropathy * pregnancy * patients with urine output \< 600 ml/12 h

Keywords: erythropoietin
correlation of the non-invasive cardiopulmonary management (cpm) wearable device with measures of congestion in heart failure

Conditions: Heart Failure

Summary: fluid status and congestion can be determined by the cpm wearable device and correlates with invasive measures, non-invasive measures and biochemical markers of congestion and changes in congestion.

hf is associated with frequent and lengthy hospitalisations. these hospitalisations are usually as a result of congestion. the signs of congestion that can be recognised by physicians or health care professionals such as lung crackles or worsening of peripheral oedema are often seen at a late stage before an intervention can be made to prevent overt decompensation and admission to hospital. recognising changes in excess fluid status either before a patient becomes unwell or during decongestion treatment is highly desirable so that timely treatment can be started or so that treatment can be adjusted based on an individual's response to therapy. the ability to assess patients by applying a single, non-invasive device would potentially provide a useful tool for assessing a patient's congestion levels and allow patients with progressive deterioration to be identified earlier.

Eligibility criteria:
inclusion criteria: written informed consent * male or female over18 years of age cohort a * meet european society of cardiology 1 (esc) criteria for diagnosis of hf * undergoing clinically-indicated rhc cohort b * established on haemodialysis for \>90 days * undergoing haemodialysis with target volume removal ≥1.5 litres fluid cohort c * meet esc criteria for diagnosis of hf including heart failure * requiring treatment with intravenous (iv) diuretics training cohort * meet esc criteria for diagnosis of hf including heart failure * requiring treatment with intravenous (iv) diuretics exclusion criteria: * unable to consent to inclusion in study due to cognitive impairment * allergies or skin sensitivities to silicone-based adhesive * skin breakdown or dermatological condition on the left chest or breast areas or chest wall deformity where the device is placed * pregnancy or breast-feeding * conditions that may confound congestion assessments * covid-19 infection.
homoarginine supplementation in patients after stroke

Conditions: Deficiency; Diet

Summary: this study represents a follow-up of the previous study "single and multiple doses of an oral formulation of l-homoarginine in healthy human subjects" (nct02675660). this study will evaluate the applicability of an oral formulation of l-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * ischemic stroke (ct or mri), high-risk transient ischemic attack (abcd2-score \>= 4) or acute central retinal artery occlusion * serum homoarginine \</= 2.1 umol/l * signed informed consent exclusion criteria: * no acute stroke * serum homoarginine \> 2.1 umol/l * heart failure (nyha \> 1) * chronic kidney disease (gfr \<60 ml/min) * not competent * pregnancy, lactation * no or withdrawn signed informed consent

Keywords: homoarginine
a study comparing exenatide with basal insulin in achieving a target hba1c with minimum weight gain in type 2 diabetes patients

Conditions: Type 2 Diabetes

Summary: this is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (oads) and once-daily insulin glargine plus oads with respect to glycemic control, as measured by hemoglobin a1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on oads.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * currently being treated with the following: dual or triple oral therapy - on a stable combination and dose for at least 3 months. * hba1c between 7.5% and 10.0%. * bmi \>27. exclusion criteria: * receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study. * have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study. * treatment with the following medications: \*insulin as outpatient therapy within last 3 months; \*meglitinides, or acarbose within the last 3 months; \*regular use of any drugs that directly affect gastrointestinal motility; \*any previous (study) therapy with exenatide or glucagon-like peptide-1 (glp-1) analogue; \*anti-obesity agent use within the last 3 months. * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Keywords: diabetes exenatide insulin glargine lilly amylin
influence of apelin levels on postoperative cognitive disorders after orthopedic surgery in elderlies (apocognit)

Conditions: Delirium

Summary: no successful strategy is proposed to patients submitted to important surgery to reduce the incidence of postoperative cognitive disorders (pocd) onset. this project propose to measure plasma levels of apelin in wide population submitted to orthopedic surgery. apelin could be involved in anti-inflammatory processes. apelin levels before and after surgery correlated to postoperative cognitive disorders symptom measured by pet-scan could be an important predictive or diagnostic marker to adapt therapeutic strategy to fight against postoperative cognitive disorders.

it has been now clearly shown that important surgery with general anesthesia could be strongly associated to postoperative cognitive disorders few months after the intervention especially in elderlies. no strategy is really efficient to fight against this phenomenon that could lead to alzheimer disease development. in order to prognosticate and characterize the potential risk to develop cognitive troubles after a surgery, this study propose to evaluate the potential predictive capacity of apelin in a cohort of young and old adult undergoing an orthopedic surgery. apelin is a peptide involved in different physiological as well physiopathological pathways. this peptide, involved in osteogenesis and inflammatory processes, has also been described to be neuroprotective. yet, hippocampic neuroinflammation has been related in case of postoperative cognitive disorders in human as well as in mice model of surgery. taken together, these results seem to indicate that apelin could be a therapeutic target and be predictive of the postoperative cognitive disorders onset. this study will measure plasma apelin levels in young and old adult one day before and after a programed orthopedic surgery. moreover, to correlate apelin amounts with inflammation processes, protocol will quantify inflammatory cytokines in plasma (il6, il1, tnfα). these results will be compared to measures of brain b-amyloid deposit assessed by pet-scan technology. the follow-up of the patients will be done during 3 months in order to evaluate the postoperative cognitive disorders or the cognitive troubles associated to surgery (memory fail, decrease of cognitive reserve...).

Eligibility criteria:
inclusion criteria: * patients submitted to a programed orthopedic surgery * patients with pre- and post-surgery check-up. exclusion criteria: * non programed orthopedic surgery (emergency) * patients with sepsis * patients submitted to orthopedic surgery but with ambulatory management. * existence of justice backup, curators or supervision. * absence of indication for a pre- or post-surgery check-up.

Keywords: postoperative cognitive disorders pocd inflammation surgery
prevalence of chronic venous disease in general population

Conditions: Chronic Venous Insufficiency

Summary: this study is designed to find prevalence and risk factors for chronic venous disease (cvd) in the general population. all the resident, who live in a single rural settlement will be invited to participate.

the study has cross-sectional design. all the residents aged 10 and more, living in the single rural settlement located in central russia will be invited to participate in the study. those who agree, will be examined both clinically and by duplex ultrasound. medical history of participants will be taken, demographic data will be collected. possible factors that may influence cvd development will be registered. signs and symptoms of cvd will be registered. duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.

Eligibility criteria:
inclusion criteria: * residents living in the rural settlement where study will be conducted * both female and male * age 10 years and more * agree to participate * signed infromed consent exclusion criteria: * age 9 years and less * not signed informed consent

Keywords: chronic venous disease prevalence risk factors
low-dose il-2 plus ifn-alpha immunotherapy as adjuvant treatment of renal carcinoma.

Conditions: Carcinoma, Renal Cell

Summary: the aim of this study is to compare the efficacy (in terms of event-free survival and overall survival) of an adjuvant therapy with ifn-alpha plus low-dose of il2 vs a wait-and-see program in patient with radically operated renal cell carcinoma.

for pts with non-metastatic rcc, no standard adjuvant treatment exists. immunotherapy (it) using ifn and/or il2 is effective in metastatic disease setting. low and chronically repeated doses of il2 plus ifn induce a persistent stimulation of the immune system with no relevant toxicity. surgically treated rcc pts were randomized to the following arms: a) low-dose it; b) control arm. it consisted of a 4-week cycle of s.c. il2 (5 days/wk, 1 million ui/sqm bid d 1,2 and 1 million ui/sqm x 1 d 3,4,5) + ifn (1,8 million ui/sqm d 3,5 of each week). cycles were repeated every 4 months for the first 2 years and every 6 months for the remaining 3 years. each patient received 12 cycles in 5 years. inclusion criteria were as follows: histological diagnosis of rcc, age \ 2,5 cm), t2, t3 a-b-c; pn0-pn3, m0; good cardiac and renal function and no autoimmune disease.

Eligibility criteria:
inclusion criteria: * diagnosis histologically confirmed of renal cells carcinoma (every histotype); * age \< 75 years * radical surgical removal of the tumor: total or partial nephrectomy within previous 3 months * patient classified as t1 (with diameter \> 2,5 cm), t2, t3 a-b-c; in presence of involvement of loco-regional lymph-nodes (staging n1, n2, n3, tnm class.), metastases should have been completely removed during nephrectomy * absence of distant metastases; * written informed consent exclusion criteria: * tumor diameter equal or less than 2,5 cm; * previous chemotherapy or ormonotherapy o immunotherapy; * renal insufficiency \>3 mg/dl); * no symptomatic arrhythmias or autoimmune disease

Keywords: carcinoma, renal cell low-dose interleukin adjuvant immunotherapy
find the adequate dose of nalbuphine for laparoscopic cholecystectomy

Conditions: Post Operative Pain; Opioid Side Effects

Summary: this study evaluate the adequate dose of mutonpain for laparoscopic cholecystectomy in the management of post operative pain. the investigators will randomize patients into three groups to compare the analgesia effects and side effects.

nalbuphine is a fda approved noncontrolled drug of opioid. and it had been applied for post operative pain for different surgeries, claiming that less nausea and vomiting with the same analgesic effect when comparing with morphine. however, several studies concerning post pain management usually used nalbuphine 0.15-0.3 mg/kg for laparoscopic cholecystectomy. if the analgesic effect of nalbuphine is similar with morphine, less nalbuphine injection could reduce the side effects of opioid. the investigators will randomize patients into three groups of different initial nalbuphine dose for post laparoscopic cholecystectomy surgical pain, and set patient control analgesia machine with nalbuphine for further pain management. if the pain or side effects of opioid were intolerable, the investigators will change pain medications into nsaids or other adequate medications to comfort the patient. the primary outcome were numerical rating pain score and consumption of nalbuphine. the secondary outcomes were nausea, vomiting, pruritus and satisfactory score, and if any other medications use.

Eligibility criteria:
inclusion criteria: * patient accept laparoscopic cholecystectomy * age:20-80 years old exclusion criteria: * nalbuphine allergy * chronic pain * active liver disease that would affect metabolization of nalbuphine * patient who had regular pain medications * patient who could not cooperate to the evaluation of the survey * dementia or other psychiatric disease

Keywords: nalbuphine dose
the effect of rtms in patients with spinal cord injury (rtms:repetetive transcranial magnetic stimulation)

Conditions: Spinal Cord Injury

Summary: it is postulated that high frequency repetitive transcranial magnetic stimulation (rtms) can decrease the corticospinal inhibition and enhance the motor recovery. this study is aimed to investigate the effect of high frequency rtms on lower extremity motor recovery and gait parameters in patients with chronic motor incomplete traumatic spinal cord injury (sci).

a sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (\>1 year) motor incomplete traumatic sci were randomized into real rtms group (n=14) or sham rtms group (n=14). real rtms (20 hz, a total of 1600 stimuli) or sham r tms were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). in addition to rtms sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance. lower extremity motor score (lems), the temporal-spatial gait parameters measured by 3d gait analysis, walking index for sci-ii (wisci-ii) scale and 10 meters walking test were assessed at baseline, 3 weeks (after the treatment sessions) and 5 weeks (follow-up).

Eligibility criteria:
inclusion criteria: * the diagnosis of motor incomplete cervical or thoracic spinal cord injury (asia c or d), spinal cord injury due to trauma at least one year previously * the ability to walk at least 10 meters independently or with assisted devices such as cane / canadian, age (18-45 years). all participants signed the informed consent form. exclusion criteria: * the presence of other musculoskeletal or neurological diseases that may prevent walking, lower motor neuron lesion (cauda equina and conus medullaris) * family history of epilepsy * the presence of brain injury * the presence of cranium defect * the presence of pacemaker * pregnancy

Keywords: r tms spinal cord injury motor recovery, gait
a study to assess treatment satisfaction, patient-reported outcomes, effectiveness, and safety of a fixed-dose combination of calcipotriene/betamethasone dipropionate pad cream in the treatment of mild-to-moderate plaque psoriasis of the scalp in adults

Conditions: Plaque Psoriasis

Summary: the main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of calcipotriene/betamethasone dipropionate (cal/bdp) pad cream in a real-world setting.


Eligibility criteria:
inclusion criteria: 1. adult (greater than or equal to \[\>=\] 18 years) male or female participants with mild-to-moderate plaque psoriasis of the scalp (defined as scalp-pga score of 2 or 3 at baseline) with or without involvement of the trunk and limbs, and who may or may not have been previously treated (treatment-naive participants) with other anti-psoriatic therapies. 2. participants who have been prescribed cal/bdp pad cream (wynzora®) treatment to manage plaque psoriasis of the scalp according to smpc in routine clinical practice. 3. willingness and ability to participate in the study; participants must give their written consent to participate. exclusion criteria: 1. participants with severe plaque psoriasis, per physician global assessment. 2. participants with erythrodermic, exfoliative or pustular psoriasis. 3. participants previously treated with systemic drugs for psoriasis (conventional or biologic) within the last 12 weeks prior to inclusion. 4. concomitant systemic treatment with anti-psoriatic drugs. 5. concomitant treatment of any type for plaque psoriasis of the scalp. 6. hypersensitivity to the active substances or to any of the excipients of cal/bdp pad cream (wynzora®). 7. participants with known disorders of calcium metabolism. 8. participants with viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds. 9. pregnant or breastfeeding women, except when the potential benefit justifies the potential risk. 10. participants unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study. 11. participants for whom medical chart is inaccessible to physicians to complete baseline data collection.

Keywords: mild-to-moderate plaque psoriasis prospective psoriasis pro-scalp plaque psoriasis of the scalp
assessing the efficacy and tolerability of azarga® (brinzolamide 1%/timolol 0.5% fixed combination) as replacement therapy in patients on combigan® (brimonidine 0.2%/timolol 0.5% fixed combination) therapy in brazil

Conditions: Glaucoma

Summary: the purpose of this study was to assess the efficacy and tolerability of changing to azarga® from prior combigan® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye). * be on a stable intraocular pressure (iop) lowering regimen within 30 days of the screening visit. * iop considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period. * best corrected visual acuity of 6/60 (20/200 snellen; 1.0 logmar) or better in each eye. * iop between 19 and 35 mmhg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy. * other protocol-defined inclusion criteria may apply. exclusion criteria: * presence of other primary or secondary glaucoma not listed in inclusion criteria #2. * history of ocular herpes simplex. * abnormality preventing reliable applanation tonometry. * corneal dystrophies. * concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. blepharitis or non-clinically significant conjunctival injection is allowed. * intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the screening visit. * risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. * progressive retinal or optic nerve disease from any cause. * use of systemic medications known to affect iop which have not been on a stable course for 7 days prior to the screening visit or an anticipated change in the dosage during the course of the study. * pregnant or lactating. * other protocol-defined exclusion criteria may apply.

Keywords: primary open-angle glaucoma ocular hypertension pigment dispersion glaucoma